MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNICUT 4.2 RES BLADE 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number	283345
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the customer in (b)(6) that during a shoulder repair procedure on (b)(6) 2022, it was observed that there were metal debris while using the omnicut 4.2 res blade device.The procedure was completed successfully with no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation, however the customer provided 3 photos of the shaver handpiece, however, the blade is not shown in the photos.A manufacturing record evaluation was performed for the finished device a2107008 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the inspection of the photos, this complaint cannot be confirmed.The photos provided does not contain relevant images to provide a root cause.Hands on analysis should provide the evidence necessary to provide a root cause.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: OMNICUT 4.2 RES BLADE 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13931153
• Report Number: 1221934-2022-00952
• Device Sequence Number: 4131451
• Product Code: HRX
• UDI-Device Identifier: 10886705022472
• UDI-Public: 10886705022472
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: 283345
• Device Catalogue Number: 283345
• Device Lot Number: A2107008
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown